Description of Event or Problem · 1
THE THERMACOR 1200 INFUSION SYSTEM WAS USED AT (B)(6) HOSPITAL. AFTER 1 1/2 HOURS INTO THE SURGERY, THE HOSPITAL NOTICED THE THERMACOR UNIT WAS NOT INFUSING BLOOD. IT WAS STATED THAT THE LACK OF INFUSION WAS DUE TO THE TWISTED RETURN LINE ON THE CASSETTE. THE CASSETTE WAS CHANGED OUT WITH A SECOND CASSETTE. THE HOSPITAL DID ENCOUNTER PROBLEMS REMOVING THE FIRST CASSETTE DUE TO THE WAY THE INITIAL CASSETTE RETURN LINE HAD BEEN CONNECTED TO THE 3 SPIKE SET. THE FIRST CASSETTE WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE YELLOW LUER LOCK SCREW WAS CONNECTED AND TIGHTENED INCORRECTLY. THE YELLOW LUER LOCK SCREW SHOULD BE USED TO TIGHTEN BUT INSTEAD IT APPEARS THAT THE CLEAR BASE UNDERNEATH WAS TIGHTENED. IT APPEARS THAT THIS INCORRECT TIGHTENING AND TWISTING CAUSED RESTRICTED FLOW. THE RETAIN SAMPLE WAS REVIEWED FOR ANY ISSUE OF THIS TYPE; THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. THE SURGERY WAS DELAYED SLIGHTLY DUE TO THE CHANGING OF THE CASSETTES; HOWEVER, NO PATIENT INJURY WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. REVIEWING PAST HISTORY OF COMPLAINTS FOR (B)(6) HOSPITAL, IT WAS NOTED THAT THIS SAME TYPE OF ISSUE WAS NOTED IN 2017. MEDICAL SOLUTIONS (MSI), DISTRIBUTOR FOR SMISSON-CARTLEDGE BIOMEDICAL, DISCUSSED THE ISSUE WITH THE BIOMED AT THE HOSPITAL. THE HOSPITAL WAS INFORMED THAT THE KINKED OR TWISTED RETURN LINE WOULD CAUSE LIMITED FLOW RATE OR ERROR CODE, "UNCLAMP RETURN LINE". MSI ALSO INFORMED THE BIOMED THAT THE RETURN LINE IS NOT A QUICK DISCONNECT, AND IT IS RECOMMENDED THAT THE YELLOW SCREW LOCK SHOULD BE USED TO TIGHTEN AND CONNECT THE CASSETTE ONTO THE 3 SPIKE SET RETURN LINE. TO FURTHER ELIMINATE THE ISSUE, THE ENDCAP HAS BEEN CHANGED TO A GREEN CAP. THE GREEN CAP SHOULD BE REMOVED AND THE YELLOW SCREW LOCK SHOULD BE USED TO TIGHTEN AND CONNECT THE CASSETTE ONTO THE 3 SPIKE SET RETURN LINE. MSI HAS OFFERED MORE TRAINING IF NEEDED BY THE HOSPITAL.